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Regulatory CMC Associate


Hays is recruiting for several positions as Regulatory CMC Associate for our client AstraZeneca. This is a temporary assignment during which you will be employed by Hays and work at AstraZeneca in Södertälje. The assignment will start as soon as possible and will be ongoing for 12 months.  

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration.

CMC Regulatory Compliance & Stability is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain.

The role
 
The Regulatory CMC Associate generates CMC documentation presented in the required format to the agreed timetable, for worldwide submissions. You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory documentation.

You may also coordinate assembly of submission-ready documents to support lifecycle submissions.

You will keep business wide electronic systems up to date to be consistent with regulatory submissions and commitments.

The role will be based in Södertälje, Sweden, and you will work in a team of 8-10 people.

Minimum Requirements - Education and Experience

 • Degree in Chemistry or Pharmacy or Chemical Engineering
• Fluently spoken and written English and Swedish
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
• Experience in Post Approval Regulatory CMC including CMC documentation authoring is desirable

 Skills and Capabilities

• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• Ability to work with short and/ or changing timelines
• Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
• Good communication skills
• Knowledge of information and document management technology and electronic/paper publishing software • IT software skills

Application
If you are interested in the position please apply as soon as possible since we will be reviewing applications continuously. 


Sammanfattning

Jobbtyp:
Uthyrning
Industri
Pharma
Ort
Stockholm
Specialisering
Life Sciences
Ref:
896313
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Tala med en konsult

Tala med Moa Palm, specialistkonsulten som hanterar denna position, i Stockholm

Hays, Sturegallerian, Stureplan 4C, Stockholm, Stockholm, 114 35

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